2015-2019年成都市武侯区老年人群肺炎球菌疫苗接种安全性分析

目的评价国产23价肺炎球菌多糖疫苗在成都市武侯区60岁及以上老年人群中大规模使用的安全性,为肺炎防治中相关免疫接种提供科学依据。方法通过中国疑似预防接种异常反应(AEFI)信息管理系统,收集2015-2019年成都市武侯区老年人群接种国产23价肺炎球菌多糖疫苗后发生AEFI个案数据,采用SPSS 21.0软件进行数据分析,分类资料采用χ~2检验,等级资料用秩和检验,检验水准α=0.05。结果共接种73 610人,累计报告22例AEFI,AEFI发生率为29.89/10万。全身不良反应的发生率为19.02/10万,局部反应发生率为27.17/10万,未见罕见和极罕见不良反应。结论由成都市生物制品研究所生产的23价肺炎球菌多糖疫苗在老年人群中大规模使用具有良好的安全性。     

老年人同时接种23价肺炎球菌多糖疫苗与流感病毒亚单位疫苗的安全性观察

目的 提高老年人对同时接种23价肺炎球菌多糖疫苗（PPV23）和流感病毒亚单位疫苗的安全性认识.方法 2012年10-12月对符合接种条件的≥60岁的老年人在接种流感病毒亚单位疫苗的同时接种23价肺炎球菌多糖疫苗（须分别注射于不同手臂）,观察接种后30 min内的即时反应、72 h内的局部反应和全身反应. 结果 不良反应发生率36.2％,发生的预防接种反应都是一般反应,并以局部反应为主,且无1人发生急性过敏反应和疑似异常反应.流感病毒亚单位疫苗的局部反应发生率为11.9％,低于PPV23 （28.5％,x2=20.07,P＜0.01）;健康老人与患有慢性疾病的老人同时接种疫苗后不良反应发生率差异无统计学意义（x2=1.67,P＞0.05）. 结论 老年人同时接种23价肺炎球菌多糖疫苗和流感病毒亚单位疫苗是安全的、可耐受的.     

23价肺炎球菌多糖疫苗临床试验

目的评价23价肺炎球菌多糖疫苗的安全性和免疫原性。方法23价肺炎球菌多糖疫苗免疫不同年龄组人群,观察局部及全身反应,并检测血清抗体滴度。结果试验组接种后出现的注射部位总疼痛率为30.8%。2人注射部位出现弱、中反应的红肿,反应率为0.23%。全身反应主要为弱反应,反应率为0.6%。试验组免后抗体平均滴度4.03,阳性对照组为4.15;抗体阳转率试验组为86.4%,阳性对照组为72.5%。试验组与阳性对照组全身发热和局部疼痛反应差异无统计学意义。试验组与阳性对照组的免疫原性相近。结论23价肺炎球菌多糖疫苗是安全有效的。     

七价肺炎球菌结合疫苗的安全性监测评价

[目的]评价七价肺炎球菌结合疫苗的安全性。[方法]2010年10～11月对215名到济南市中心医院预防接种门诊接种七价肺炎球菌结合疫苗者,年龄为3个月至3岁的婴幼儿进行七价肺炎球菌结合疫苗(沛儿prevenar)接种后不良反应的临床观察,分别于接种疫苗后30min和12、24、48、72h观察不良反应,直至不良反应消失。[结果]共观察215名婴幼儿,19人(占8.84%)发生不良反应,共23例次,不良反应发生率为8.84%。3个月至1岁11个月组接种112人,发生不良反应的10人,不良反应发生率8.93%;2～3岁组接种103人,发生不良反应的9人,不良反应发生率为8.74%,二者差异无统计学意义(P>0.05)。局部反应为14例次,全身反应为9例次,均于对症治疗3日内缓解、消失。[结论]临床观察证明接种七价肺炎球菌结合疫苗有较好的安全性。     

四价流感病毒裂解疫苗和23价肺炎球菌多糖疫苗在≥60岁老年人中同时接种的安全性评价

目的分析60岁及以上老年人群同时接种四价流感病毒裂解疫苗与23价肺炎球菌多糖疫苗后的安全性。方法于2021年11月至2022年5月, 在江苏省泰州市招募符合标准的60岁及以上老年人群, 最终纳入2 461名受试者。每名受试者同时接种1剂四价流感病毒裂解疫苗和1剂23价肺炎球菌多糖疫苗, 并在接种后28 d内进行安全性观察。采用主动填报和定期回访的方式收集受试者接种疫苗后的安全性信息。结果 2 461名受试者完成两种疫苗的同时接种, 并完成了接种后28 d的安全性观察随访。受试者年龄为(70.66±6.18)岁;男性占54.61%(1 344名);均为汉族居民;罹患基础疾病者占22.51%(554名)。同时接种后0～28 d内, 总体不良反应的发生率为2.07%(51/2 461), 主要为1级不良反应[1.83%(45/2 461)], 未观察到4级及以上不良反应以及与疫苗相关的严重不良事件。局部不良反应发生率为0.98%(24/2 461), 主要症状为接种部位疼痛[0.93%(23/2 461)];全身不良反应的发生率为1.42%(35/2 461), 其主要症状为发热[0.85%...     

23价肺炎球菌多糖疫苗预防老年人下呼吸道感染的效果考察

目的为了对23价肺炎球菌多糖疫苗预防社区老年人下呼吸道感染(Lowerrespiratorytractinfeceions,LRTIs)的效果、成本-效益及接种后的不良反应进行分析。方法抽取600名老年人均分为疫苗组和对照组,疫苗组接种后随访2周观察不良反应。同期追踪两组1年LRTIs、抗生素使用、住院情况、直接医疗费用。结果疫苗对LRTIs、抗生素使用、住院保护效率分别为69.7%、72.6%、65.9%。亚组分析,疫苗可减少慢性阻塞性肺疾病(Chronicobstructivepulmonarydisease,COPD)、冠状动脉硬化性心脏病(冠心病)患者LRTIs、抗生素使用、住院;减少糖尿病、高血压患者LRTIs、抗生素使用。接种疫苗的成本效益比为1∶2.06,净效益66471.65元。接种后不良反应多为局部反应,经热敷或休息1~3d可缓解。结论社区老年人,尤其是有COPD、冠心病的老年人,接种23价肺炎球菌多糖疫苗具有一定的保护效率、成本-效益和安全性。     

老年人接种23价肺炎球菌多糖疫苗的安全性观察

为了解老年人接种23价肺炎球菌多糖疫苗(Pneumonia Vaccine,PnV)的安全性,在成都市对≥65岁身体健康的128人接种23价PnV后的局部反应、全身反应进行了观察,按<预防接种手册>(迮文远主编,上海科学技术文献出版社,1997.15)判定结果.     

接种23价肺炎球菌多糖疫苗的安全性观察

肺炎球菌感染以老年人及婴幼儿最为严重,主要引起中耳炎、鼻窦炎、咽炎/扁桃体炎、下呼吸道感染(主要是肺炎)、菌血症、脑膜炎等。接种23价肺炎球菌多糖疫苗是预防肺炎球菌感染的有效途径。为了了解使用23价肺炎球菌多糖疫苗安全性,柳城县疾病预防控制中心对2012年10月接种23价肺炎疫苗的415人开展了临床观察。     

河北省23价肺炎球菌多糖疫苗安全性分析

目的 分析河北省23价肺炎球菌多糖疫苗(23-valent pneumococcal polysaccharide vaccine, PPSV-23)接种后疑似预防接种异常反应(adverse events following immunization, AEFI)的发生特征,评价该疫苗的安全性。方法 通过中国疾病预防控制信息系统AEFI监测模块收集河北省2020年1月1日至2022年12月31日PPSV-23接种后AEFI个案,分析其报告发生情况。结果 PPSV-23的AEFI报告发生率为56.12/10万剂,不良反应发生率为55.50/10万剂,其中一般反应报告发生率为53.94/10万剂,异常反应报告发生率为1.56/10万剂。AEFI以一般反应为主,主要发生在接种后<1 d,总体转归情况良好。结论 河北省PPSV-23总体安全性良好,仍需加强其安全性监测工作。     

赴美移民多种疫苗同时接种安全性的前瞻性研究

目的探讨在中国人群中开展多种疫苗不同部位同时接种的安全性,为其进一步推广提供科学依据。方法选择2004年6月～2006年8月到广东国际旅行卫生保健中心接受预防接种的赴美移民申请者为调查对象,采用自填式调查表和电话报告相结合的方法收集受种者接种后不良反应情况,并与国外研究结果进行比较。结果772名受种者,接种后7d内不良反应报告率为49.6%,其中局部反应报告率为39.8%,全身反应为20.1%,与国外同类研究结果相仿。Logistic回归分析发现,女性不良反应报告率显著高于男性,接种23价肺炎球菌多糖疫苗者局部反应报告率较高,而同时接种疫苗针次未纳入回归模型。结论多种疫苗不同部位同时接种所出现的不良反应较轻微,其发生率不会因同时接种多种疫苗而增加;在中国人群中开展多种疫苗同时接种是安全可行的。     

23价肺炎球菌多糖疫苗对成人肺炎球菌性疾病的预防效果

  目的  了解云南省玉溪市 ≥ 60岁老年人免费接种23价肺炎球菌多糖疫苗（PPV23）的安全性,为当地开展肺炎球菌多糖疫苗的接种工作提供参考依据。  方法  收集云南省疑似预防接种异常反应（AEFI）监测信息管理系统中2018年1月1日 — 2020年12月31日玉溪市老年人免费接种PPV23的AEFI数据,对AEFI的发生情况、发生时间、发生程度和病例转归情况进行了描述性分析。  结果  玉溪市2018年1月1日 — 2020年12月31日免费接种PPV23的 ≥ 60岁老年人共243670人,累计报告AEFI者40例,AEFI发生率为16.42/10万;其中一般反应占77.5 %,异常反应占12.5 %,心因性反应和偶合反应分别占5 %,上述病例均好转与痊愈。  结论  玉溪市老年人免费接种PPV23的安全性良好。     

Missing spleen: indication for pneumococcal vaccination

Two female patients, aged 39 and 52 years, developed severe pneumococcal meningitis. Both patients had undergone splenectomy in the past (one after trauma and one for idiopathic thrombocytopenic purpura) and pneumococcal vaccination was only given immediately after the splenectomy. After antibiotic treatment and intensive care one patient remained disabled and the other patient died. There is a higher risk of developing severe sepsis after splenectomy, with Streptococcus pneumoniae being the causative micro-organism in more than 50% of cases. Vaccination after splenectomy in order to prevent a severe sepsis syndrome is very important. Indications for the 7 valent pneumococcal conjugate vaccine and the 23 valent polysaccharide vaccine are given.     

The cost-effectiveness of pneumococcal vaccination in healthy adults over 50: An exploration of influential factors for Belgium

BackgroundA recent trial demonstrated the 13 valent conjugate pneumococcal vaccine (PCV13) to be effective against invasive and non-invasive pneumococcal disease in healthy adults. PCV13 might therefore be considered as an alternative to the 23 valent polysaccharide vaccine (PPV23).AimTo explore the cost-effectiveness of vaccinating healthy adults over 50, with either PCV13 or PPV23 alone, or with a combined strategy using both PCV13 and PPV23.MethodsA static multi-cohort model was developed simulating the consequences of pneumococcal vaccination in adults over 50 from a health care payer's perspective, for different scenarios of duration of vaccine protection and serotype evolution.ResultsAt currently expected prices, PCV13 vaccination of healthy adults over 50 is unlikely to be cost-effective either compared with no vaccination or in combination with PPV23 versus PPV23 only.ConclusionFurther research is needed on vaccine efficacy of the combination strategy and of risk groups, as well as the duration of vaccine protection. Serotype evolutions under the influence of the childhood PCV program should be closely monitored.     

Total and serotype-specific pneumococcal antibody titres in children with normal and abnormal humoral immunity

A heptavalent pneumococcal conjugate vaccine (PCV-7) protects children against invasive pneumococcal disease. The aim of this study was to evaluate immunoglobulin subclass and serotype-specific pneumococcal antibody responses to vaccination in children with a history of recurrent or severe bacterial infections. Pneumococcal IgG, IgG1, IgG2 titres were assayed by ELISA, and nine serotype concentrations measured using a nonaplex bead assay in 145 children investigated for recurrent or severe infections. Children mounted an exclusively IgG1 response after vaccination with two doses of PCV-7 and a dose of 23 valent pneumococcal polysaccharide vaccine (PPV-23), with pneumococcal IgG2 antibody titres remaining low to negligible. Measurement of serotype-specific responses demonstrated that although PCV-7 specific serotype responses increased significantly post-vaccination, specific IgG against two of the serotypes not covered by PCV-7 but only by PPV-23 remained low. We conclude that in contrast to antibody response to natural infection with Pneumococcus or pneumococcal polysaccharide vaccines which are often of a IgG2 subclass, responses in children after PCV-7 are of IgG1 subclass. Serotype-specific IgG were useful in determining the protection against specific pneumococcal strains, and showed that the PPV-23 did not broaden protection against non-PCV-7 serotypes.     

Comparative reactogenicity and immunogenicity of 23 valent pneumococcal vaccine administered by intramuscular or subcutaneous injection in elderly adults

23 Valent pneumococcal vaccine is provided to the elderly through public health programs in many countries. However there is no clear recommendation regarding its route of administration (subcutaneous or intramuscular). In a randomised, observer blind study of 254 elderly subjects, the immunogenicity of a 23 valent pneumococcal vaccine was not influenced by its route of administration. A low rate of systemic adverse reactions was observed with the vaccine (subcutaneous and intramuscular both 6.3%). Local adverse reaction rates were; intramuscular 7.1% and subcutaneous 18.9% and these were predicted by: * Pre-vaccination antibody titres>1 microg/ml, odds ratio 22.4 (8.06-74.84) compared with pre-vaccination antibody titre<1 microg/ml. * Female gender, odds ratio 5.0 (1.85-14.83) compared with male gender. * Subcutaneous injection route, odds ratio 3.20 (1.13-9.13) compared with intramuscular injection route. * Female gender subcutaneous injection route, odds ratio 2.99 (1.10-8.70) compared with female gender intramuscular injection route. These data support the intramuscular injection of 23 valent pneumococcal vaccine, especially in elderly females.     

A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination

IntroductionA 20-valent pneumococcal conjugate vaccine, PCV20, was developed to expand protection against vaccine-preventable pneumococcal disease. PCV20 contains the components of the 13-valent pneumococcal conjugate vaccine, PCV13, and includes capsular polysaccharide conjugates for 7 additional serotypes. Thus, PCV20 may cover those additional serotypes in individuals previously vaccinated with PCV13 or provide benefits of immunization with a conjugate vaccine to individuals previously immunized with a pneumococcal polysaccharide vaccine. This study described the safety and immunogenicity of PCV20 in adults ≥65 years of age with prior pneumococcal vaccination.MethodsThis phase 3, multicenter, randomized, open-label study was conducted in the United States and Sweden. Adults ≥65 years of age were enrolled into 1 of 3 cohorts based on their prior pneumococcal vaccination history (23-valent pneumococcal polysaccharide vaccine [PPSV23], PCV13, or both PCV13 and PPSV23). Participants were randomized 2:1 within their cohort to receive a single dose of PCV20 or PCV13 in those with prior PPSV23 only, and PCV20 or PPSV23 in those with prior PCV13 only; all participants with prior PCV13 and PPSV23 received PCV20. Safety was assessed by prompted local reactions within 10 days, systemic events within 7 days, adverse events (AEs) within 1 month, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. Immune responses 1 month after PCV20 were assessed.ResultsThe percentages of participants reporting local reactions, systemic events, and AEs after PCV20 administration were similar across cohorts and comparable with the PCV13 and PPSV23 control groups. SAE and NDCMC rates were low in all groups. Robust immune responses, including opsonophagocytic antibody responses, to the 20 vaccine serotypes were observed 1 month after PCV20 regardless of prior pneumococcal vaccination.ConclusionsPCV20 was well tolerated and immunogenic in adults ≥65 years of age previously vaccinated with different pneumococcal vaccine regimens.Clinicaltrials.gov NCT03835975.     

Persistence of immunity to conjugate and polysaccharide pneumococcal vaccines in frail,hospitalised older adults in long-term follow up

BackgroundData on long-term antibody responses to pneumococcal vaccines in the elderly, especially the frail elderly at greatest risk of severe disease, are limited. We followed up participants in a randomised trial of the immunogenicity of 23-valent polysaccharide vaccine (23vPPV) and 7 valent pneumococcal conjugate vaccines (PCV7) in hospitalised older adults.MethodsWe measured antibody to vaccine serotypes by standardised enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic (OPA) assays. A follow up study was conducted six years after vaccination with 23vPPV alone or with PCV7 followed by 23vPPV six months later.ResultsOf 215 surviving trial participants, 136 (63%) completed follow up; 62 received 23vPPV and 74 received PCV7 + 23vPPV. There was no significant difference in death and readmission between arms. Antibody levels by ELISA and OPA did not differ significantly between the two study arms at 72 months post-vaccination. ELISA and OPA antibody remained higher than baseline except for OPA antibody to 4, 6A, 6B, 9v, 19F and 23F, including in subjects with undetectable immunity at baseline.DiscussionWhile ELISA responses in both study arms remained high 6 years post-vaccination, considerable waning was observed by OPA in both study arms, which should be considered given the current single-dose recommendation in Australia. Further research is needed to inform pneumococcal vaccine recommendations in people over the age of 65.     

Phase 1/2 study of a novel 24-valent pneumococcal vaccine in healthy adults aged 18 to 64 years and in older adults aged 65 to 85 years

BackgroundPneumococcal diseases remain prevalent despite available polysaccharide and conjugate vaccines. This phase 1/2 study evaluated safety/tolerability and immunogenicity of a novel 24-valent pneumococcal vaccine (ASP3772) based on high-affinity complexing of proteins and polysaccharides.MethodsPneumococcal vaccine–naïve adults aged 18–85 years were randomized to receive either ASP3772 or PCV13 (13-valent conjugate vaccine). Participants received a single intramuscular injection of ASP3772 (1-, 2-, or 5-µg dose per polysaccharide) or PCV13. A separate, nonrandomized group of PCV13-vaccinated participants (65–85 years) received PPSV23 (23-valent polysaccharide vaccine). Assessments were obtained through Day 7 for reactogenicity, through Day 30 for safety and tolerability, and through Month 6 for serious adverse events. Immunogenicity was measured at Day 30 using assays for functional opsonophagocytic activity (OPA) and pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G for each serotype.ResultsIn both age cohorts, the most frequently reported local reactions were self-limited tenderness and pain after ASP3772 at all dose levels or after PCV13, occurring within 2–3 days. Fatigue, headache, and myalgia were the most frequently reported systemic reactions following either vaccine. Robust OPA responses for all serotypes were observed across all ASP3772 dose groups in both age cohorts. Older adults (aged 65–85 years) who received ASP3772 had significantly higher immune responses to several PCV13 serotypes and all non-PCV13 serotypes than participants who received PCV13. OPA responses to the ASP3772 5-µg dose were significantly higher for several serotypes in naïve participants than in older adults with prior exposure to PCV13 who were administered PPSV23 in this study.ConclusionsThese results demonstrate that ASP3772 is well tolerated, highly immunogenic, and in adults may offer significantly broader protection than existing pneumococcal vaccines.Clinicaltrials.gov: NCT03803202     

Opsonophagocytic activity following a reduced dose 7-valent pneumococcal conjugate vaccine infant primary series and 23-valent pneumococcal polysaccharide vaccine at 12 months of age

Opsonophagocytic activity (OPA) was measured following reduced infant doses of 7-valent pneumococcal conjugate vaccine (PCV-7) with or without 23-valent pneumococcal polysaccharide vaccine (PPV-23) at 12 months, and subsequent re-exposure to a small dose of pneumococcal polysaccharide antigens (mPPS) at 17 months. Fijian infants were randomized to receive 0, 1, 2, or 3 PCV-7 doses. Half received PPV-23 at 12 months and all received mPPS at 17 months. OPA was performed on up to 14 serotypes. Three and 2 PCV-7 doses resulted in similar OPA for most PCV-7 serotypes up to 9 months and for half of the serotypes at 12 months. A single dose improved OPA compared with the unvaccinated group. PPV-23 significantly improved OPA for all serotypes tested but in general, was associated with diminished responses following re-challenge.     

慢性阻塞性肺疾病患者流感疫苗和23价肺炎球菌多糖疫苗接种研究进展

近年来国内外慢性阻塞性肺疾病（COPD）患者流感疫苗和23价肺炎球菌多糖疫苗（PPV23）接种有效性的相关研究发现,接种流感疫苗和PPV23可显著降低COPD患者的流感和肺炎感染风险,减少疾病的急性加重以及与之相关的住院,尤其是接种流感疫苗还可降低患者诱发缺血性心脏病、急性冠脉综合征、室性心律失常、肺癌、痴呆和死亡的风险,二者联合接种保护作用更加显著。国内外权威指南、共识均建议COPD患者接种流感疫苗和PPV23。目前国内流感疫苗和肺炎球菌疫苗接种率均偏低,且在COPD患者中的应用研究较少。应采取有效措施加强知识普及和指南宣传,提高疫苗接种率。同时还应进一步加强COPD患者接种流感和PPV23的临床研究,尤其是联合接种的临床效益分析,以切实改善COPD患者的生存现状和预后。